Cognitive ChangeZEMBRINNCT05471804
Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract
A study testing Sceletium tortuosum in people with Cognitive Change and Stress, Psychological, run by Northumbria University at 1 site in United Kingdom.
Trial summary
This study employs a randomized controlled trial to test the cognitive enhancing and stress relieving potential of the product Zembrin® in healthy adults when consumed over an 8 week period. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Stress, Psychological
- What is being tested?
- Sceletium tortuosum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must self-assess themselves as being in good health Aged 30 to 50 years at the time of giving consent
Who cannot join
- Participants are not eligible to take part if they:
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments for female participants, those medications used in the treatment of reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- Are pregnant, seeking to become pregnant or lactating.
Show all 26Show fewer
- Are menopausal/post-menopausal
- Have learning and/or behavioural difficulties such as dyslexia or ADHD
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoke tobacco or vape nicotine or use nicotine replacement products
- Take any illicit social drugs, including cannabis
- Have excessive caffeine intake (>500 mg per day)
- Have relevant food intolerances/ sensitivities
- Have taken antibiotics within the past 4 weeks
- Have taken dietary supplements eg. Vitamins, omega 3 fish oils, herbal extracts, cannabadiol etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taken are out of choice and not medically prescribed or advised). Existing and consistent use of vitamin D supplements and protein shakes are permitted
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Sleep disorders or are taking sleep aid medication
- Any known active infections
- Have oral disease
- Does not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption
Trial locations and contacts
1 site in 1 country.
David Kennedy, Professor contact
United Kingdom1 site, 1 recruiting
- Recruiting
Brain Performance and Nutrition Research Centre
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
Emma Wightman, Dr, 0191 227 3725, emma.l.wightman@northumbria.ac.uk
David Kennedy, Professor, 0191 243 7720, david.kennedy@northumbria.ac.uk
About this study
Official title: Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract (Zembrin™): a Randomised, Double Blind, Placebo-controlled, Parallel-groups Trial
This study employs a randomized controlled trial to test the cognitive enhancing and stress relieving potential of the product Zembrin® in healthy adults when consumed over an 8 week period.
Read the detailed description
The aim of the proposed randomized, double-blind, placebo-controlled, parallel groups study is to assess the effects of 8 weeks supplementation with Zembrin®, in 30-50 year old healthy adults, on cognitive function, mood, psychological and physiological stress responses during a laboratory stressor, fatigue and sleep quality. The trial will utilize the COMPASS cognitive assessment system and a range of mood measures and will employ the Observed Multitasking Stressor (OMS), with psychological state and physiological responses assessed before and after, and cognitive function assessed during, the stressor. The cognitive/mood assessments will take place prior to (Day -1 with respect to treatment) and after 8 weeks supplementation with Zembrin. An interim mood/fatigue assessment will take place online (Cognimapp) with a baseline measurement collected between the screening visit and Day -1 and post dose measurements collected after 7 and 28 days 1 and 4 weeks of treatment.
- Conditions
- Cognitive Change, Stress, Psychological
- Being tested
- Sceletium tortuosum
- Keywords
- Zembrin, Sceletium tortuosum, COMPASS
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sceletium tortuosumDietary supplement
Also called Zembrin
Zembrin® is a proprietary low-alkaloid extract of Sceletium tortuosum, often consumed by healthy humans in order to decrease anxiety and stress and improve cognitive function under stressful situations
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | An inert tablet with the same physical appearance as the experimental intervention tablet Receives: Dietary Supplement: Sceletium tortuosum |
| Zembrin | Experimental | 25 mg per day of Sceletium tortuosum extract (Zembrin®) Receives: Dietary Supplement: Sceletium tortuosum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective stress
This outcome will be assessed via changes on the Perceived Stress Scale (PSS). This is a 10 item scale scored from 0 (NEVER) to 4 (very often) with a higher score indicating greater stress.
Measured: 56 days
Secondary outcomes (10)
Mental fatigue
This outcome will be assessed via changes on the Multidimensional Fatigue Inventory (MFI-20). This is a 20 item questionnaire scored from 1 (yes, that is true) to 7 (no, that is not true) with higher scores indicating more fatigue.
Measured: 56 days
Subjective happiness
This outcome will be assessed via changes on the Oxford Happiness Questionnaire (OHQ). This is a 29 item questionnaire scored from 1 (strongly disagree) to 6 (strongly agree) with a higher score indicating greater happiness.
Measured: 56 days
Subjective alertness
This outcome will be assessed via changes on the Visual Analogue Scale (VAS) for alertness. This VAS is a 100 mm line with 'not alert' and 'alert' anchoring each end of the line. This is scored from mm distance along the line towards 'alert'; with a higher score indicating greater alertness.
Measured: 56 days
Physical fatigue/ sleep quality
This outcome will be assessed via changes on the Athens Insomnia Scale (within the MFI-20). This is scored as per the MFI detailed in outcome 2 above.
Measured: 56 days
Cognitive function
This outcome will be assessed via changes on the cognitive task outcomes (measured via COMPASS). COMPASS is a proprietorial software platform for delivering a range of cognitive tasks; assessing domains like memory and attention, with tasks scored for accuracy (% correct) and speed (msec).
Measured: 56 days
Physiological induced stress
This outcome will be assessed via changes in heart rate (beats per minute) during the observed multitasking stressor. Higher values indicate greater stress.
Measured: 56 days
Psychological induced stress
This outcome will be assessed via changes on the State portion Trait Anxiety Inventory (STAI). The state portion of this questionnaire comprises 20 items which is scored from 1 (not at all) to 4 (very much so) with a higher score indicating greater stress.
Measured: 56 days
Galvanic skin response
This outcome will be assessed via changes in galvanic skin response (micro siemans) during the observed multitasking stressor). Higher values indicate greater stress.
Measured: 56 days
Salivary cortisol
This outcome will be assessed via changes in salivary cortisol (nmol/L) during the observed multitasking stressor. Higher values indicate greater stress.
Measured: 56 days
Alpha Amylase
This outcome will be assessed via changes in alpha amylase (nmol/L) during the observed multitasking stressor. Higher values indicate greater stress.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start18 May 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- HG&H Pharmaceuticals
- Responsible party
- Principal investigator, Emma Wightman, Northumbria University
- Investigators
- Emma Wightman, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471804
- Sponsor's protocol ID
- 61CC1
- Acronym
- ZEMBRIN
- Status last verified
- Jul 2022
- First submitted
- 13 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The is no plan to share the raw individual participant data with anyone other than the research team here at Northumbria University and the study sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Effects of 8 Weeks Supplementation With Sceletium Tortuosum Extract (Zembrin™): a Randomised, Double Blind, Placebo-controlled, Parallel-groups Trial
- ClinicalTrials.gov ID
- NCT05471804
- Acronym / sponsor ID
- ZEMBRIN / 61CC1
- Conditions
- Cognitive Change, Stress, Psychological
- Keywords
- Zembrin, Sceletium tortuosum, COMPASS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- HG&H Pharmaceuticals
- Study start
- 18 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study employs a randomized controlled trial to test the cognitive enhancing and stress relieving potential of the product Zembrin® in healthy adults when consumed over an 8 week period.
Detailed description
The aim of the proposed randomized, double-blind, placebo-controlled, parallel groups study is to assess the effects of 8 weeks supplementation with Zembrin®, in 30-50 year old healthy adults, on cognitive function, mood, psychological and physiological stress responses during a laboratory stressor, fatigue and sleep quality. The trial will utilize the COMPASS cognitive assessment system and a range of mood measures and will employ the Observed Multitasking Stressor (OMS), with psychological state and physiological responses assessed before and after, and cognitive function assessed during, the stressor. The cognitive/mood assessments will take place prior to (Day -1 with respect to treatment) and after 8 weeks supplementation with Zembrin. An interim mood/fatigue assessment will take place online (Cognimapp) with a baseline measurement collected between the screening visit and Day -1 and post dose measurements collected after 7 and 28 days 1 and 4 weeks of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo control | Placebo comparator | Dietary Supplement: Sceletium tortuosumAn inert tablet with the same physical appearance as the experimental intervention tablet |
| Zembrin | Experimental | Dietary Supplement: Sceletium tortuosum25 mg per day of Sceletium tortuosum extract (Zembrin®) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must self-assess themselves as being in good health Aged 30 to 50 years at the time of giving consent
Key exclusion criteria (26 listed)
- Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled hay fever, high cholesterol and reflux-related conditions. There may be other, unforeseen, exceptions and these will be considered on a case-by-case basis; i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance.
- Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments for female participants, those medications used in the treatment of reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- Are pregnant, seeking to become pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sceletium tortuosumAlso: ZembrinZembrin® is a proprietary low-alkaloid extract of Sceletium tortuosum, often consumed by healthy humans in order to decrease anxiety and stress and improve cognitive function under stressful situations | Dietary supplement | Placebo control, Zembrin |
Primary outcome
Subjective stress
Time frame: 56 days
This outcome will be assessed via changes on the Perceived Stress Scale (PSS). This is a 10 item scale scored from 0 (NEVER) to 4 (very often) with a higher score indicating greater stress.
10 secondary outcomes
Mental fatigue
Time frame: 56 days
Subjective happiness
Time frame: 56 days
Subjective alertness
Time frame: 56 days
Physical fatigue/ sleep quality
Time frame: 56 days
Cognitive function
Time frame: 56 days
Physiological induced stress
Time frame: 56 days
Psychological induced stress
Time frame: 56 days
Galvanic skin response
Time frame: 56 days
Salivary cortisol
Time frame: 56 days
Alpha Amylase
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No. The is no plan to share the raw individual participant data with anyone other than the research team here at Northumbria University and the study sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kennedy, Professor contact
Emma Wightman, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sceletium tortuosum in people with Cognitive Change and Stress, Psychological, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Wightman, PhD (+44(0)191 234 ext. 7252, emma.l.wightman@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective stress (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.